EU → US Device Access

SIC invent Sweden AB

SE-MF-000002493 · Sweden · Askim

SIC invent Sweden AB is registered in the European database on medical devices as a manufacturer, with 346 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIb211
Class IIa135

Among these devices, 215 are declared sterile, 62 implantable.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entrySIC INVENT AG (CH) · FDA 3004443656
Devices in EUDAMED346
Country of registrationSweden
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in Sweden

All Sweden manufacturers →